Medical waste differs from hazardous waste. Hazardous waste is regulated by the US EPA (and related state rules) under the Resource Conservation and Recovery Act. Medical waste is not covered federal environmental laws or US EPA regulations (with the exception of a medical waste that also meets the definition of hazardous waste). Rather, medical waste is mostly controlled by state law and associated regulations. In addition to state environmental agency laws/rules, aspects of medical waste management are also controlled by the Occupational Safety & Health Administration (federal and/or state) and Department of Transportation (federal and state).

Each of our 50 states have developed rules and implemented regulations for medical waste. The state rules vary to some extent, including terminology. Depending on which state you live in, you may hear the terms regulated medical waste, biohazardous waste or infectious medical waste. In most cases, these terms all refer to the same thing: that portion of the medical waste stream that may be contaminated by blood, body fluids or other potentially infectious materials, thus posing a significant risk of transmitting infection.

Most states have regulations covering packaging, storage, and transportation of medical waste. Some states require health care facilities to register and/or obtain a permit. State rules may also cover the development of contingency plans, on-site treatment, training, waste tracking, recordkeeping, and reporting.

In most states, the environmental protection agency is primarily responsible for developing and enforcing regulations for medical waste management and disposal. Although in some states, the department of health may play an important role or even serve as the primary regulatory agency. Where both agencies are involved, typically the department of health is responsible for on-site management and the environmental agency is responsible for transportation and disposal.

OSHA, whether it is the U.S. Department of Labor Occupational Safety & Health Administration or an OSHA state program (24 states operate their own program), regulates several aspects of medical waste, including management of sharps, requirements for containers that hold or store medical waste, labeling of medical waste bags/containers, and employee training. These standards are designed to protect healthcare workers from the risk of exposure to bloodborne pathogens. However, they also help to systematically manage wastes, which benefit the public and environment.

Regulated medical waste is defined by the US Department of Transportation as a hazardous material. DOT rules mostly apply to transporters rather than healthcare facilities; although, knowledge of these rules is important because of the liability associated with shipping waste off-site.

Definition of Regulated
Medical Waste

There are five categories of regulated medical wastes
in New York:

Cultures and stocks of infectious agents

Human pathological wastes

Human blood and blood products

Sharps

Animal waste

In addition to these five categories, the Commissioner
of Health may designate specific items as RMW. For the complete
definition of regulated medical waste see Statutes, regulations
and guidelines below.

Managing Regulated
Medical Wastes

In this
section, you will find the key
rules that apply to the management of the Regulated
Medical Waste (RMW) stream inside your facility.

Registration,
Permits

Generators of regulated medical waste are not required
to register with the state of New York and no RMW generator permits
are required by the state of New York. Facilities that want to
perform on-site treatment of RMW must submit a plan to DEC (see on-site
treatment requirements above).

Storage

RMW must be kept separate from other wastes in an
area that is designated and clearly labeled with the universal warning
sign or the word “biohazard.” The storage area must
be ventilated and located to minimize exposure to the public and is
accessible only to authorized personnel.

There are no maximum time limits for storage of
RMW and no approval is required for this activity. The waste must be
maintained in a nonputrescent state, using refrigeration, when necessary.

Containers for RWM must be prominently marked with
the universal warning sign or the word “biohazard.”

Training
Requirements

All employees involved with the on-site management
of RMW must be trained in accordance with the requirements of the OSHA
Exposure to Bloodborne Pathogens regulations (29
CFR 1910.1030).

Recordkeeping
and Reporting

Generators must maintain records of the quantity
of regulated medical waste generated, and the disposition of those
wastes. An annual report must be submitted to the Commissioner
of Environmental Conservation indicating the quantity of regulated
medical waste and its disposition. A copy of each report to the
Commissioner of Environmental Conservation must be submitted to the
Commissioner of Health.

Treatment and Disposal of
Regulated Medical Waste

In this section, you will find information on the
proper final disposition of the Regulated Medical Waste (RMW) stream,
including RMW sent off-site and RMW treated on-site.

Off-Site
Transport/Disposal

The generator is responsible for properly packaging
and labeling RWM for off-site transport and for completing a Medical
Waste Tracking Form (MWTF). For transport off-site, untreated
RMW must be placed in impermeable red plastic bags and labeled with
the universal warning sign or the word “biohazard.” Each
bag containing untreated RMW must be labeled and placed in a secondary
rigid type container before off-site transport. The rigid containers
may be of any color, but must be leak proof and labeled with the universal
warning sign or the word “biohazard.” Sharps must be packaged
in rigid, puncture and break resistance, and leak proof containers
labeled with the universal warning sign or the word “biohazard.” These
sharps containers must also be labeled and placed in a secondary rigid
type container before off-site transport.

Each primary container (red bag), sharps or fluid
container destined for off-site treatment and disposal must include
the generator facility name and address. Each secondary container
must include the generator facility name and address, the transporter’s
name and permit number, the date of shipment and identification of
the RMW contents (e.g., sharps, chemotherapeutic waste, pathological
waste), and include the universal warning sign or the word “biohazard.” In
addition, a MWTF is also required.

Containers of RMW must not be compacted and must
remain intact until transfer or disposal.

Containers contaminated with spilled or leaked RMW
must be repackaged before transport.

If RMW is mixed with hazardous or radioactive waste
it must be managed as hazardous or radioactive waste.

On-site
Treatment Requirements

Before treating RMW on-site, a facility must develop
an operational plan that contains specific elements (e.g., type of
waste, methods of segregation, training schedule, storage/containment
procedures, treatment methods, disposal method, and emergency/contingency
plan). The plan must be submitted to a local DEC office and the
DEC Division of Solid & Hazardous Materials, for approval.

Treatment or disposal of RWM must be done by autoclaving
or other techniques approved by the Department of Public Health to
render the waste noninfectious. A list of approved treatment
technologies is available by calling 518-485-5378.

Properly treated RMW should be disposed of as solid
waste , provided it does not meet the definition of hazardous waste
and is accompanied by a certificate, which evidences such treatment. All
sharps must be rendered unrecognizable prior to disposal (i.e., sharps
that are merely treated are still considered RMW and cannot be disposed
of in a landfill).

Properly treated RMW from facilities with approved
treatment processes may mix the treated RMW with other solid waste
if a certificate of treatment form accompanies the waste to the authorized
disposal facility.

More Information

In this section, you will find links to points of
contacts at the New York State agencies responsible for regulating healthcare
facility waste, links to the text of the regulations, and additional
resources that you might find of interest on this topic.

Contacts

New
York State Department of Health. Contact NYDOH for questions
regarding definitions of regulated medical waste, on-site treatment
and disposal strategies (see bottom of NYDOH for points of contact).

OSHA Regulations

In addition to the state medical waste environmental
regulations there are some Occupational Safety and Health Administration
(OSHA) rules that apply to medical/infectious waste. New York is one
of 24 states operating an approved occupational safety and health program. However,
the New York program only covers the workplace safety and health of public
sector employees only. Private sector employees in New York are covered
by Federal
OSHA. OSHA state and federal rules (Occupational Exposure to Bloodborne
Pathogens Standards) impact various aspects of medical/infectious waste,
including management of sharps, requirements for containers that hold
or store medical/infectious waste, labeling of medical/infectious waste
bags/containers, and employee training. These requirements can be found
in the HERC section entitled OSHA Standards for Regulated Waste.

Additional Resources

Managing
Regulated Medical Waste. Regulated
medical waste information provided by the New York Department of
Health. Includes details on definitions of regulated medical
wastes, management guidelines and disposal options.

Regulated
Medical Waste. Regulated medical
waste information provided by the New York Department of Environmental
Conservation. Includes links to various guidance documents
covering RMA storage and disposal.